During certain manufacturing processes, vessels containing various fluids are used. Often it is necessary to transfer fluid into or out of a vessel during the process and do so in a manner that eliminates or substantially eliminates the possibility of leakage. In particular, the need to transfer fluid in such a manner often arises in the manufacturing and processing of pharmaceuticals, biopharmaceuticals, or other biotechnology applications where processes are conducted in vessels of varying shapes and sizes. The need for fluid transfer into and out of a vessel arises in other applications and industries as well, including but not limited to, the production of food, cosmetics, paint, chemicals, including hazardous chemicals, and the transfer and handling of semiconductor fluids.
Regardless of the industry, during transfers or sampling, the fluid should not leak. Leakage exposes the contents of the vessels to the environment, thereby compromising the substantially sterile conditions in which the fluid was kept. In addition, when making such transfers, it is desirable to keep the environment surrounding a vessel free from contamination by the contents of the vessel or a sample taken therefrom. It is often the case that, throughout the manufacturing process, there is a need to maintain fluid communication with the interior of the vessel by way of, for example, tubing extending through a fluid transfer interface from the exterior of the vessel into the interior of the vessel, or from the interior to the exterior. To accomplish a substantially aseptic and leak-free transfer, it is desirable to control the environment through which the fluid flows. For example, the pathway from a vessel to a sample container should be substantially aseptic along the entire pathway. Furthermore, it is desirable that the fluid transfer interface be safe for use, reliable, and of relatively low-cost construction.
It is also desirable to transfer fluid using a fluid transfer interface that is pre-sterilized and disposable. A pre-sterilized, disposable fluid transfer interface avoids the need for an operator to sterilize the interface for use. Further, certain sterilization processes can damage fluid transfer interfaces and render them useless before their first use.
Known fluid transfer interfaces that serve as vessel closures utilize connections that extend from the body of an interface and then terminate with barbed ends or luer fittings onto which additional tubing or other fluid pathways are connected. Fluid transfer interfaces incorporating such terminations are deficient because, in the case of barbed attachments, the tubing connected to the barb can pull free. In the case of luers, including locking luer connections, fluid can still leak out of the fluid pathway thereby contaminating the environment surrounding the vessel and compromising the sterility of the process.
Thus, what is needed is a fluid transfer interface with a body from which continuous fluid transfer conduits extend, whereby the conduits extend through and are secured to the body, and to which a fluid control device may be connected. What is further needed is a low cost, disposable fluid transfer interface that is connected to a vessel, for example, a bioreactor bag, and to which fluid control devices may be connected that creates a substantially aseptic fluid pathway into and out of the vessel that does not suffer from the shortcomings of a barbed or luer termination, or other means of joining fluid pathways.